Myelo-proliferative neoplasms including essential thrombocythemia, Polycythemia Vera, Prefibrotic myelofibrosis MedDRA version: 20.0 Level: PT Classification code 10077465 Term: Myeloproliferative neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10015494 Term: Essential thrombocythemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Eliquis
Pharmaceutical Form: Tablet
Trade Name: Xarelto
Pharmaceutical Form: Tablet
Trade Name: Aspirine Protec
Pharmaceutical Form: Gastro-resistant capsule
Sponsors
CHRU de Brest
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with diagnosis of PV or ET or PreMF according to WHO or BSCH criteria (bone marrow biopsy not compulsory). - Patients with JAK2V617F mutation (threshold allele burden > 1%). - Patients considered as “high-risk” patients: 1°) based on age (> 60-year-old) 2°) based on thrombotic history (compatible with antithrombotic randomization) but aged = 18-year-old. - Length of time from MPN diagnostic to inclusion will not exceed 12 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Contra-indication to aspirin or DOAC due to allergic situation or recent history of major bleeding - Formal indication of treatment with LDA or DOAC (thus precluding randomization) - Inability to give informed consent - Patients under curatorship/guardianship - Concomitant use of a strong inhibitor or inducer of CYP3A4 (like Ruxolitinib). - Chronic liver disease or chronic hepatitis - Renal insufficiency with creatinine 2 or life expectancy <12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that low-dose DOAC is more effective than LDA in the primary prevention of arterial or venous thrombosis in JAK2V617F-positive high-risk MPN patients. ;Secondary Objective: Secondary objectives greater than 1000 characters (refer to the protocol);Primary end point(s): Occurrence of arterial or venous thromboembolic events at 24 months.;Timepoint(s) of evaluation of this end point: 3, 6, 12, 18 and 24 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Occurrence of major and clinically relevant non-major bleedings as defined by ISTH at 24 months. - Occurrence of arterial thromboembolic events at 24 months. - Occurrence of venous thromboembolic events at 24 months. - Occurrence of serious adverse events others than thrombosis and bleedings at 24 months. - Occurrence of atrial fibrillation episodes at 24 months. - Overall survival and event free survival (events defined above) at 24 months. - Occurrence of adjudicated mortality (non cardiovascular and cardiovascular) at 24 months - Therapeutic adherence will be studied (Girerd auto-questionnaire) during the study treatment period of 24 months. - Quality of life will be studied (EQ-5D-5L and MPN-SAF auto-questionnaire) during the study treatment period of 24 months. - Evaluation of costs and incremental cost utility ratio (cost per QALY) of low-dose DOAC compared to LDA. ;Timepoint(s) of evaluation of this end point: 3, 6, 12, 18 and 24 month | — |
Countries
Canada, France
Contacts
Public ContactDauphou EDDI
CHRU de Brest
Outcome results
None listed